BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5637549 · Received May 6, 2016

    Report

    Report Number
    3007981285-2016-78456
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    April 14, 2016
    Report Date
    April 15, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BLOOD GLUCOSE (BG) LEVELS THAT WERE RANGING FROM 223-500 MG/DL WITH MODERATE KETONES. THE CUSTOMER CHANGED THE SUPPLIES ON THE PUMP. DURING TROUBLESHOOTING WITH TANDEM CUSTOMER TECHNICAL SUPPORT (CTS), AN OCCLUSION WAS FOUND IN THE PUMP HISTORY THAT HAD OCCURRED EARLIER THAT DAY AND THE CUSTOMER HAD REPORTED SEEING AIR BUBBLES IN THE TUBING. AS THE CUSTOMER HAD CHANGED THE SUPPLIES, A SYSTEM CHECK TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSION WAS UNABLE TO BE DETERMINED. CTS ASSISTED THE CUSTOMER WITH REMOVING THE AIR BUBBLES FROM THE TUBING. THE CUSTOMER REPORTED THAT THE BG LEVEL HAD BEEN LOWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291875 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other